Systems and methods of integrated real-time visualization

ABSTRACT

Systems and methods for integrated real-time visualization while performing a minimally invasive procedure within anatomic passageways include a flexible catheter having one or more first lumens and a first positioning system, an imaging probe having one or more imaging elements, and a sealing device. In some embodiments, the sealing device includes a plurality of second lumens and the flexible catheter and the imaging probe are each optionally deployed through a respective one of the second lumens. In some embodiments, the one or more imaging elements include one or more ultrasound transducers. In some embodiments, the sealing device seals the anatomic passageways at a sealing location using one or more balloons, and the anatomic passageways distal to the sealing location are collapsed. In some embodiments, the first positioning system includes one or more position sensors. In some embodiments, the procedure is performed after the passageways are collapsed.

RELATED APPLICATIONS

This patent application claims priority to and the benefit of the filingdate of U.S. Provisional Patent Application 62/350,455, entitled“Systems and Methods of Integrated Real-Time Visualization,” filed Jun.15, 2016, which is incorporated by reference herein in its entirety.

FIELD

The present disclosure is directed to systems and methods for performingminimally invasive procedures using integrated real-time visualization.

BACKGROUND

Minimally invasive medical techniques are intended to reduce the amountof tissue that is damaged during medical procedures, thereby reducingpatient recovery time, discomfort, and harmful side effects. Suchminimally invasive techniques may be performed through natural orificesin a patient anatomy or through one or more surgical incisions. Throughthese natural orifices or incisions clinicians may insert minimallyinvasive medical instruments (including surgical, diagnostic,therapeutic, or biopsy instruments) to reach a target tissue location.One such minimally invasive technique is to use a flexible and/orsteerable catheter that is inserted into anatomic passageways andnavigated toward a region of interest within the patient anatomy. Aminimally invasive medical device, due to its generally small size, doesnot always provide a surgeon, clinician, or operator or other medicalpersonnel with sufficient imaging capabilities to identify the targettissue location, such as when the target tissue location is locatedbelow a surface of a passageway through which the minimally invasivemedical device is introduced.

Accordingly, it would be advantageous to provide integrated real-timevisualization to aid a surgeon during minimally invasive medicaltechniques.

SUMMARY

The embodiments of the invention are best summarized by the claims thatfollow the description.

Consistent with some embodiments, a medical system for performing aminimally invasive procedure within anatomic passageways includes aflexible catheter including a plurality of first lumens and a sealingdevice, an imaging probe including one or more imaging elements whereinthe imaging probe is configured to be slideably received within a firstof the plurality of first lumens; a working catheter configured to beslideably received within a second of the plurality of first lumens, anda positioning system configured to determine a position of at least oneof a distal portion of the flexible catheter, a distal portion of theimaging probe, and a distal portion of the working catheter within theanatomic passageways. In some embodiments, the sealing device includes aplurality of second lumens and the flexible catheter and the imagingprobe are each optionally deployed through a respective one of thesecond lumens. In some embodiments, the one or more imaging elementsinclude one or more ultrasound transducers. In some embodiments, thesealing device seals the anatomic passageways at a sealing locationusing one or more balloons, and the anatomic passageways distal to thesealing location are collapsed.

Consistent with some embodiments, a method of planning a medicalprocedure on target anatomy includes receiving an anatomical modelcomprising a model of anatomic passageways, determining a target anatomywithin the anatomic passageways, determining a first location toposition a distal portion of a working catheter where one or moremedical instruments deployed through one or more lumens of the workingcatheter have access to the target anatomy, determining a secondlocation within the anatomic passageways to position a distal portion ofan imaging probe where one or more imaging elements of the imaging probeare able to obtain images of the target anatomy, and determining a thirdlocation within the anatomic passageways to position a distal portion ofa flexible catheter wherein the third location is proximal to the firstlocation and to the second location.

Consistent with some embodiments, a medical system for performing aminimally invasive procedure within anatomic passageways includes aworking catheter comprising one or more first lumens, an imaging probecomprising one or more imaging elements positioned near a distal portionof the imaging probe to obtain images of a target anatomy, a flexiblecatheter comprising a sealing device; and a first positioning system fordetermining a position of a distal portion of the working catheter, aposition of the distal portion of the imaging probe, and a position of adistal portion of the flexible catheter within the anatomic passageways.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory innature and are intended to provide an understanding of the presentdisclosure without limiting the scope of the present disclosure. In thatregard, additional aspects, features, and advantages of the presentdisclosure will be apparent to one skilled in the art from the followingdetailed description.

BRIEF DESCRIPTIONS OF THE DRAWINGS

FIG. 1 is a simplified diagram of a teleoperated medical systemaccording to some embodiments.

FIG. 2 is a simplified diagram of a medical instrument system accordingto some embodiments.

FIG. 3 is a simplified diagram of medical instruments being introducedinto a patient according to some embodiments.

FIGS. 4A and 4B are simplified diagrams of side views of medicalinstruments within patient anatomy according to some embodiments.

FIG. 4C is a simplified diagram of a cut-away view of the medicalinstruments and patient anatomy of FIG. 4B according to someembodiments.

FIG. 4D is a simplified diagram of a cross-sectional views of themedical instruments and patient anatomy of FIG. 4B according to someembodiments.

FIG. 5 is a simplified diagram of side views of medical instrumentswithin patient anatomy according to some embodiments.

FIG. 6 is a simplified diagram of side views of medical instrumentswithin patient anatomy according to some embodiments.

FIGS. 7A and 7B are simplified diagrams of side views of medicalinstruments within patient anatomy according to some additionalembodiments.

FIG. 7C is a simplified diagram of a cut-away view of the medicalinstruments and patient anatomy of FIG. 7B according to some additionalembodiments.

FIGS. 7D and 7E are simplified diagrams of cross-sectional views of themedical instruments and patient anatomy of FIG. 7B according to someadditional embodiments.

FIG. 8 is a simplified diagram of a method of performing a procedureusing integrated real-time imaging according to some embodiments.

FIG. 9 is a simplified diagram of a method of performing a procedureusing integrated real-time imaging according to some additionalembodiments.

Embodiments of the present disclosure and their advantages are bestunderstood by referring to the detailed description that follows. Itshould be appreciated that like reference numerals are used to identifylike elements illustrated in one or more of the figures, whereinshowings therein are for purposes of illustrating embodiments of thepresent disclosure and not for purposes of limiting the same.

DETAILED DESCRIPTION

In the following description, specific details are set forth describingsome embodiments consistent with the present disclosure. Numerousspecific details are set forth in order to provide a thoroughunderstanding of the embodiments. It will be apparent, however, to oneskilled in the art that some embodiments may be practiced without someor all of these specific details. The specific embodiments disclosedherein are meant to be illustrative but not limiting. One skilled in theart may realize other elements that, although not specifically describedhere, are within the scope and the spirit of this disclosure. Inaddition, to avoid unnecessary repetition, one or more features shownand described in association with one embodiment may be incorporatedinto other embodiments unless specifically described otherwise or if theone or more features would make an embodiment non-functional.

In some instances well known methods, procedures, components, andcircuits have not been described in detail so as not to unnecessarilyobscure aspects of the embodiments.

This disclosure describes various instruments and portions ofinstruments in terms of their state in three-dimensional space. As usedherein, the term “position” refers to the location of an object or aportion of an object in a three-dimensional space (e.g., three degreesof translational freedom along Cartesian x-, y-, and z-coordinates). Asused herein, the term “orientation” refers to the rotational placementof an object or a portion of an object (three degrees of rotationalfreedom—e.g., roll, pitch, and yaw). As used herein, the term “pose”refers to the position of an object or a portion of an object in atleast one degree of translational freedom and to the orientation of thatobject or portion of the object in at least one degree of rotationalfreedom (up to six total degrees of freedom). As used herein, the term“shape” refers to a set of poses, positions, or orientations measuredalong an object.

Various lung bronchoscopic procedures involve navigating a flexiblecatheter in proximity of a lesion or tumor within the lungs underendoscopic guidance. Once near the target lesion, a procedure can beperformed such as a biopsy where a biopsy needle can be delivered withina lumen of the flexible catheter to obtain a sample of the lesion tissuewhich is analyzed to, for example, determine whether it is cancerous ornon-cancerous. While rough guidance to the target anatomy is performedwith endoscopic visualization and the biopsy is often performed underfluoroscopy, in the case where the lesion is embedded within theparenchymal tissue, it is difficult to view and locate the lesionvisually in either endoscopic or fluoroscopic images. Thus it can bedifficult to verify whether a biopsy showing non-cancerous tissue is aresult of a patient being cancer free or a result of the biopsy needlesimply missing the lesion.

One way of being able to visualize a lesion in real time during aprocedure is to use an endo-brachial ultrasound (EBUS) probe locatednear the target anatomy, such as by placement near the target anatomyand within an airway of the lung. Ultrasound, however, does notgenerally provide usable images through air, so one option is to blockan airway of the lung by activating a sealing device collapsing one ormore airways distal to the sealing device and thus collapsing a portionof the lung containing the lesion, and then using ultrasound tovisualize the target anatomy. With a real time image of the lesionprovided by the ultrasound, a biopsy (or another procedure) may beperformed where the operator can accurately see the needle penetrate alesion and confirm that target tissue was accessed and biopsied.Additional procedures, such as ablation, cryotherapy, drug delivery,and/or the like may benefit as well from similar visualization.

A few challenges may be expected with this visualization procedure. Ingeneral, the ultrasound transducer should be positioned within a rangeof the target anatomy (e.g., within about 5 cm or so) and should bepositioned to capture images of the lesion within the target anatomy.Without suitably localizing the ultrasound transducer to both the targetanatomy and the medical instrument to be directed by the ultrasoundimages, the relative positions of the ultrasound transducer and medicalinstrument may not be adequately known. This may result in the operatorhaving to repeatedly position the transducer, collapse the lung to viewwith ultrasound, reflate the lung to insert, retract, and/or rotate theultrasound transducer semi-blindly until the lesion and medicalinstrument path is adequately visible in the ultrasound field of view.Because movement of the ultrasound transducer is more difficult in acollapsed lung, the operator would ideally prefer to position theultrasound transducer in a suitable location within proximity to thelesion prior to collapsing the lung. Thus it would be advantageous toknow the position and rotation of the ultrasonic transducer field ofview relative to the lesion and the medical instrument prior tocollapsing the lung so that as much of the positioning and alignment ofthe ultrasound transducer as possible may occur prior collapsing thelung. Thus a system providing stable positioning, accurate real-timelocalization, and controllable manipulation of the ultrasound transducerand the medical instrument during a procedure would be desirable.

FIG. 1 is a simplified diagram of a teleoperated medical system 100according to some embodiments. In some embodiments, teleoperated medicalsystem 100 may be suitable for use in, for example, surgical,diagnostic, therapeutic, or biopsy procedures within passageways of apatient's anatomy, such as the airways of lungs. As shown in FIG. 1,medical system 100 generally includes a teleoperational manipulatorassembly 102 for operating one or more medical devices 104 in performingvarious procedures on a patient P. Teleoperational manipulator assembly102 is mounted to or near an operating table O. A master assembly 106allows a physician, clinician, or operator S to view the interventionalsite and to control teleoperational manipulator assembly 102.

Master assembly 106 may be located at an operator's console which isusually located in the same room as operating table O, such as at theside of a surgical table on which patient P is located. However, itshould be understood that operator S can be located in a different roomor a completely different building from patient P. Master assembly 106generally includes one or more control devices for controllingteleoperational manipulator assembly 102. The control devices mayinclude any number of a variety of input devices, such as joysticks,trackballs, data gloves, trigger-guns, hand-operated controllers, voicerecognition devices, body motion or presence sensors, and/or the like.To provide operator S a strong sense of directly controlling the one ormore medical devices 104, the control devices may be provided with thesame degrees of freedom as the associated one or more medical devices104. In this manner, the control devices provide operator S withtelepresence or the perception that the control devices are integralwith the one or more medical devices 104.

In some embodiments, the control devices may have more or fewer degreesof freedom than the associated one or more medical devices 104 and stillprovide operator S with telepresence. In some embodiments, the controldevices may optionally be manual input devices which move with sixdegrees of freedom, and which may also include an actuatable handle foractuating instruments (for example, for closing grasping jaws, applyingan electrical potential to an electrode, delivering a medicinaltreatment, and/or the like).

Teleoperational manipulator assembly 102 supports the one or moremedical devices 104 and may include a kinematic structure of one or morenon-servo controlled links (e.g., one or more links that may be manuallypositioned and locked in place, generally referred to as a set-upstructure) and a teleoperational manipulator. Teleoperationalmanipulator assembly 102 may optionally include a plurality of actuatorsor motors that drive inputs on the one or more medical devices 104 inresponse to commands from the control system (e.g., a control system112). The actuators may optionally include drive systems that whencoupled to one or more medical devices 104 may advance the one or moremedical devices 104 into a naturally or surgically created anatomicorifice. Other drive systems may move the distal end of each of the oneor more medical devices 104 in multiple degrees of freedom, which mayinclude three degrees of linear motion (e.g., linear motion along the X,Y, Z Cartesian axes) and in three degrees of rotational motion (e.g.,rotation about the X, Y, Z Cartesian axes). Additionally, the actuatorscan be used to actuate an articulable end effector of each of the one ormore medical devices 104 for grasping tissue in the jaws in a gripper,taking a tissue sample with a biopsy device, orienting an ultrasoundtransducer, closing a passageway, and/or the like. Actuator positionsensors such as resolvers, encoders, potentiometers, and othermechanisms may provide sensor data to medical system 100 describing therotation and orientation of the motor shafts. This position sensor datamay be used to determine motion of the objects manipulated by theactuators.

Teleoperated medical system 100 may include a sensor system 108 with oneor more sub-systems for receiving information about the instruments ofteleoperational manipulator assembly 102. Such sub-systems may include apositioning system including an electromagnetic (EM) sensor system, ashape sensor system, and/or the like for determining the pose (positionand orientation), speed, velocity, pose, and/or shape of a distal endand/or of one or more segments along a flexible body that may make upeach of the one or more medical devices 104; and/or a visualizationsystem for capturing images.

Teleoperated medical system 100 also includes a display system 110 fordisplaying an image or representation of the surgical site (or site fora procedure) and the one or more medical devices 104 generated bysub-systems of sensor system 108. Display system 110 and master assembly106 may be oriented so operator S can control the one or more medicaldevices 104 and master assembly 106 with the perception of telepresence.

In some embodiments, the one or more medical devices 104 may have avisualization system (discussed in more detail below), which may includea viewing scope assembly that records a concurrent or real-time image ofa surgical site and provides the image to the clinician or operator Sthrough one or more displays of medical system 100, such as one or moredisplays of display system 110. The concurrent image may be, forexample, a two or three dimensional image captured by an endoscopepositioned within the surgical site. In some embodiments, thevisualization system includes endoscopic components that may beintegrally or removably coupled to the one or more medical devices 104.However in some embodiments, a separate endoscope, attached to aseparate manipulator assembly may be used with the one or more medicaldevices 104 to image the surgical site. In some embodiments, thevisualization system may include an ultrasound transducer located at ornear a distal end of one of the one or more medical devices 104. Thevisualization system may be implemented as hardware, firmware, softwareor a combination thereof which interact with or are otherwise executedby one or more computer processors, which may include the processors ofa control system 112. The processors of control system 112 may executeinstructions comprising instruction corresponding to processes disclosedherein and described in more detail below.

Display system 110 may also display one or more images of the surgicalsite and medical instruments captured by the visualization system. Insome examples, teleoperated medical system 100 may configure the one ormore medical devices 104 and controls of master assembly 106 such thatthe relative positions of the medical devices 104 are similar to therelative positions of the eyes and hands of operator S. In this manneroperator S can manipulate the one or more medical devices 104 and thehand control as if viewing the workspace in substantially true presence.By true presence, it is meant that the presentation of an image is atrue perspective image simulating the viewpoint of an operator that isphysically manipulating the one or more medical devices 104.

In some examples, display system 110 may present images of a surgicalsite recorded pre-operatively or intra-operatively using image data fromimaging technology such as, computed tomography (CT), magnetic resonanceimaging (MM), fluoroscopy, thermography, ultrasound, optical coherencetomography (OCT), thermal imaging, impedance imaging, laser imaging,nanotube X-ray imaging, and/or the like. The pre-operative orintra-operative image data may be presented as two-dimensional,three-dimensional, or four-dimensional (including e.g., time based orvelocity based information) images and/or as images from models createdfrom the pre-operative or intra-operative image data sets.

In some embodiments, often for purposes of imaged guided surgical ormedical procedures, display system 110 may display a virtualnavigational image in which the actual locations of the one or moremedical devices 104 are registered (i.e., dynamically referenced) withthe preoperative or concurrent images/model. This may be done to presentthe clinician or operator S with a virtual image of the internalsurgical site from a viewpoint of the one or more medical devices 104.In some examples, the viewpoint may be from a tip of one of the one ormore medical devices 104, from the perspective of an ultrasound image,and/or the like. An image of the tips of the one or more medical devices104 and/or other graphical or alphanumeric indicators may besuperimposed on the virtual image to assist operator S controlling theone or more medical devices 104. In some examples, the one or moremedical devices 104 may not be visible in the virtual image.

In some embodiments, display system 110 may display a virtualnavigational image in which the actual locations of the one or moremedical devices 104 are registered with preoperative or concurrentimages to present the clinician or operator S with a virtual image ofthe one or more medical devices 104 within the surgical site from anexternal viewpoint. An image of a portion of the one or more medicaldevices 104 or other graphical or alphanumeric indicators may besuperimposed on the virtual image to assist operator S in the control ofthe one or more medical devices 104.

Teleoperated medical system 100 may also include control system 112.Control system 112 includes at least one memory and at least onecomputer processor (not shown) for effecting control between the one ormore medical devices 104, master assembly 106, sensor system 108, anddisplay system 110. Control system 112 also includes programmedinstructions (e.g., a non-transitory machine-readable medium storing theinstructions) to implement some or all of the methods described inaccordance with aspects disclosed herein, including instructions forproviding information to display system 110. While control system 112 isshown as a single block in the simplified schematic of FIG. 1, thesystem may include two or more data processing circuits with one portionof the processing optionally being performed on or adjacent toteleoperational manipulator assembly 102, another portion of theprocessing being performed at master assembly 106, and/or the like. Anyof a wide variety of centralized or distributed data processingarchitectures may be employed. Similarly, the programmed instructionsmay be implemented as a number of separate programs or subroutines, orthey may be integrated into a number of other aspects of theteleoperational systems described herein. In one embodiment, controlsystem 112 supports wireless communication protocols such as Bluetooth,IrDA, HomeRF, IEEE 802.11, DECT, and Wireless Telemetry.

In some embodiments, control system 112 may transmit signals instructingone or more actuators of teleoperational manipulator assembly 102 tomove the one or more medical devices 104. The one or more medicaldevices 104 may extend into an internal surgical or medical site withinthe body of patient P via openings in the body of patient P. Anysuitable conventional and/or specialized actuators may be used. In someexamples, the one or more actuators may be separate from, or integratedwith, teleoperational manipulator assembly 102. In some embodiments, theone or more actuators and teleoperational manipulator assembly 102 areprovided as part of a teleoperational cart positioned adjacent topatient P and operating table O.

Control system 112 may optionally further include a virtualvisualization system to provide navigation assistance to operator S whencontrolling the one or more medical devices 104 during an image-guidedmedical procedure. Virtual navigation using the virtual visualizationsystem may be based upon reference to an acquired preoperative orintraoperative dataset of anatomic passageways. The virtualvisualization system processes images of the medical site imaged usingimaging technology such as CT, MRI, fluoroscopy, thermography,ultrasound, OCT, thermal imaging, impedance imaging, laser imaging,nanotube X-ray imaging, and/or the like. Software, which may be used incombination with manual inputs, is used to convert the recorded imagesinto segmented two dimensional or three dimensional compositerepresentation of a partial or an entire anatomic organ or anatomicregion. An image data set is associated with the compositerepresentation. The composite representation and the image data setdescribe the various locations and shapes of the passageways and theirconnectivity. The images used to generate the composite representationmay be recorded preoperatively or intra-operatively during a clinicalprocedure. In some embodiments, a virtual visualization system may usestandard representations (i.e., not patient specific) or hybrids of astandard representation and patient specific data. The compositerepresentation and any virtual images generated by the compositerepresentation may represent the static posture of a deformable anatomicregion during one or more phases of motion (e.g., during aninspiration/expiration cycle of a lung).

During a virtual navigation procedure, sensor system 108 may be used tocompute approximate locations of the one or more medical devices 104with respect to the anatomy of patient P. The location can be used toproduce both macro-level (external) tracking images of the anatomy ofpatient P and virtual internal images of the anatomy of patient P. Thesystem may implement one or more electromagnetic (EM) sensor, fiberoptic sensors, and/or other sensors to register and display a medicalimplement together with preoperatively recorded surgical images, such asthose from a virtual visualization system, are known. For example U.S.patent application Ser. No. 13/107,562 (filed May 13, 2011) (disclosing“Medical System Providing Dynamic Registration of a Model of an AnatomicStructure for Image-Guided Surgery”) which is incorporated by referenceherein in its entirety, discloses one such system. Teleoperated medicalsystem 100 may further include optional operations and support systems(not shown) such as illumination systems, steering control systems,irrigation systems, and/or suction systems. In some embodiments,teleoperated medical system 100 may include more than oneteleoperational manipulator assembly and/or more than one masterassembly. The exact number of teleoperational manipulator assemblieswill depend on the medical procedure and the space constraints withinthe operating room, among other factors. In some examples, multiplemaster assemblies allow more than one operator to control one or moreteleoperational manipulator assemblies in various combinations.

FIG. 2 is a simplified diagram of a medical instrument system 200according to some embodiments. In some embodiments, medical instrumentsystem 200 may be used as any of the one or more medical devices 104 inan image-guided medical procedure performed with teleoperated medicalsystem 100. In some examples, medical instrument system 200 may be usedfor non-teleoperational exploratory procedures or in proceduresinvolving traditional manually operated medical instruments, such asendoscopy.

Medical instrument system 200 includes an elongate instrument 202coupled to a drive unit 204. Elongate instrument 202 includes a flexiblebody 216 having proximal end 217 and distal end 218 (also “tip portion218.”) In some embodiments, flexible body 216 has an approximately 3 mmouter diameter. Other flexible body outer diameters may be larger orsmaller. Elongate instrument 202 may optionally include shape sensor 222for determining the position, orientation, speed, velocity, pose, and/orshape of the catheter tip at distal end 218 and/or of one or moresegments 224 along flexible body 216. The entire length of flexible body216, between distal end 218 and proximal end 217, may be effectivelydivided into segments 224. If medical instrument system 200 is one ofthe one or more medical devices 104 of a teleoperated medical system100, shape sensor 222 may be a component of sensor system 108. Ifmedical instrument system 200 is manually operated or otherwise used fornon-teleoperational procedures, shape sensor 222 may be coupled to atracking system 230 that interrogates shape sensor 222 and processesreceived shape data.

Shape sensor 222 may optionally include an optical fiber aligned withflexible body 216 (e.g., provided within an interior channel (not shown)or mounted externally). In some embodiments, the optical fiber has adiameter of approximately 200 μm. In some embodiments, the dimensionsmay be larger or smaller. The optical fiber of shape sensor 222 forms afiber optic bend sensor for determining the shape of elongate instrument202. In one alternative, optical fibers including Fiber Bragg Gratings(FBGs) are used to provide strain measurements in structures in one ormore dimensions. Various systems and methods for monitoring the shapeand relative position of an optical fiber in three dimensions aredescribed in U.S. patent application Ser. No. 11/180,389 (filed Jul. 13,2005) (disclosing “Fiber optic position and shape sensing device andmethod relating thereto”); U.S. patent application Ser. No. 12/047,056(filed on Jul. 16, 2004) (disclosing “Fiber-optic shape and relativeposition sensing”); and U.S. Pat. No. 6,389,187 (filed on Jun. 17, 1998)(disclosing “Optical Fibre Bend Sensor”), which are all incorporated byreference herein in their entireties. Sensors in some embodiments mayemploy other suitable strain sensing techniques, such as Rayleighscattering, Raman scattering, Brillouin scattering, and Fluorescencescattering. In some embodiments, the shape of the catheter may bedetermined using other techniques. For example, a history of the distalend pose of elongate instrument 202 can be used to reconstruct the shapeof flexible body 216 over the interval of time. As another example,historical pose, position, or orientation data may be stored for a knownpoint of an instrument system along a cycle of alternating motion, suchas breathing. This stored data may be used to develop shape informationabout flexible body 216. In some examples, a series of positionalsensors, such as electromagnetic (EM) sensors, positioned along flexiblebody 216 can be used for shape sensing. In some examples, a history ofdata from a positional sensor, such as an EM sensor, on the instrumentsystem during a procedure may be used to represent the shape of theinstrument, particularly if an anatomic passageway is generally static.In some examples, a wireless device with position or orientationcontrolled by an external magnetic field may be used for shape sensing.The history of the position of the wireless device may be used todetermine a shape for the navigated passageways.

In some embodiments, medical instrument system 200 may, optionally,include position sensor system 220. Position sensor system 220 may be acomponent of an EM sensor system with positional sensor system 220including one or more conductive coils that may be subjected to anexternally generated electromagnetic field. Each coil of EM sensorsystem used to implement positional sensor system 220 then produces aninduced electrical signal having characteristics that depend on theposition and orientation of the coil relative to the externallygenerated electromagnetic field. In some embodiments, an EM sensorsystem used to implement the positional sensor system 220 may beconfigured and positioned to measure six degrees of freedom, e.g., threeposition coordinates X, Y, Z and three orientation angles indicatingpitch, yaw, and roll of a base point or five degrees of freedom, e.g.,three position coordinates X, Y, Z and two orientation angles indicatingpitch and yaw of a base point. Further description of an EM sensorsystem is provided in U.S. Pat. No. 6,380,732 (filed Aug. 11, 1999)(disclosing “Six-Degree of Freedom Tracking System Having a PassiveTransponder on the Object Being Tracked”), which is incorporated byreference herein in its entirety. In some embodiments, shape sensor 222may also function as the position sensor because the shape of shapesensor 222 together with information about the location of the base ofshape sensor 222 (in the fixed coordinate system of patient P) allowsthe location of various points along shape sensor 222, including distalend 218, to be determined.

In some embodiments, tracking system 230 may optionally include positionsensor system 220 and shape sensor 222 for determining the position,orientation, speed, pose, and/or shape of distal end 218 and of one ormore segments 224 of medical instrument system 200. Tracking system 230may optionally be implemented as hardware, firmware, software or acombination thereof which interact with or are otherwise executed by oneor more computer processors, which may include the processors of controlsystem 112 in FIG. 1.

In some embodiments, flexible body 216 includes one or more lumens 226sized and shaped to receive corresponding medical instruments. Themedical instruments may include, for example, image capture probes,biopsy instruments, ablation devices, cryotherapeutic devices, drugdelivery needles, and/or other surgical, diagnostic, or therapeutictools. The ablation devices may include bipolar or monopolar devicesusing microwave energy, radio frequency, electrodes, ultrasoundtransducers, and/or the like. In some examples, the medical instrumentmay provide bipolar or monopolar radio frequency energy, microwaveenergy, ultrasound, cryotherapeutic energy, chemicals, direct heatand/or the like. Other end effectors may further include electricallyactivated end effectors such as electrosurgical electrodes, transducers,sensors, and/or the like.

In some embodiments, the medical instrument system 202 may include animage capture probe that includes a distal portion with a stereoscopicor monoscopic camera at or near distal end 218 of flexible body 216 forcapturing images (including video images) that are processed by avisualization system 231 for display. The image capture probe mayinclude a cable coupled to the camera for transmitting the capturedimage data. In some examples, the image capture instrument may be afiber-optic bundle, such as a fiberscope, that couples to visualizationsystem 231. In some examples the captured image data may be transmittedusing Bluetooth, WiFi, or other remote data transmission technology. Theimage capture instrument may be single or multi-spectral, for examplecapturing image data in one or more of the visible, infrared, and/orultraviolet spectrums.

In some embodiments, the medical instrument system 202 may include anultrasound transducer located at or near distal end 218 of flexible body216 for capturing ultrasound images in the region of distal end 218. Insome examples, the elongate instrument 202 may be rotated about thelongitudinal axis of flexible body 216 to allow the ultrasoundtransducer to obtain ultrasound images in a field of view located neardistal end 218. The ultrasound transducer may be coupled to one or moreelectrical wires or optical fibers for activating the ultrasoundtransducer, modulating its output, capturing return signals, and/or thelike. In some examples, ultrasound imaging devices may includeside-facing transducers, forward-facing transducers, curved transducers,and/or the like. In some examples, the ultrasonic imaging device mayconsist of one or more electronically phased, mechanically scanned,and/or mechanically steerable transducer elements and/or arrays oftransducer elements that are capable of capturing 2D, 3D, and/or 4Dultrasound images in proximity to distal end 218.

In some examples, the ultrasound transducer may be included in a medicalinstrument, such as a needle, that may be extended beyond distal end 218and optionally inserted into the solid anatomy of the patient. Theultrasound transducer may be included in an imaging probe configured tobe received within one of the lumens 226 of the elongate instrument 202.In some examples, the imaging probe may be a radial probe or a radialEBUS probe that may be rotated about the longitudinal axis of the radialprobe to allow the ultrasound transducer to obtain ultrasound images ina field of view located near distal end 218. In some examples, theimaging probe may include ultrasound transducers configured to beside-facing, forward-facing, curved, and/or the like. In some examplesthe imaging probe may include ultrasound transducers which include aplurality of phased array transducer elements which are electronicallyphased to capture 2D, 3D, and/or 4D ultrasound images.

The medical instrument may additionally house cables, linkages, and/orother actuation controls (not shown) that extend between proximal end217 and distal end 218 to controllably bend and/or actuate a distal endof the medical device inserted through one of the lumens 226. Steerableinstruments are described in detail in U.S. Pat. No. 7,316,681 (filed onOct. 4, 2005) (disclosing “Articulated Surgical Instrument forPerforming Minimally Invasive Surgery with Enhanced Dexterity andSensitivity”) and U.S. patent application Ser. No. 12/286,644 (filedSep. 30, 2008) (disclosing “Passive Preload and Capstan Drive forSurgical Instruments”), which are incorporated by reference herein intheir entireties.

Flexible body 216 may also house cables, linkages, or other steeringcontrols (not shown) that extend between drive unit 204 and distal end218 to controllably bend distal end 218 as shown, for example, by brokendashed line depictions 219 of distal end 218. In some examples, at leastfour cables are used to provide independent “up-down” steering tocontrol a pitch of distal end 218 and “left-right” steering to control ayaw of distal end 218. Steerable catheters are described in detail inU.S. patent application Ser. No. 13/274,208 (filed Oct. 14, 2011)(disclosing “Catheter with Removable Vision Probe”), which isincorporated by reference herein in its entirety. In embodiments inwhich medical instrument system 200 is actuated by a teleoperationalassembly, drive unit 204 may include drive inputs that removably coupleto and receive power from drive elements, such as actuators, of theteleoperational assembly. In some embodiments, medical instrument system200 may include gripping features, manual actuators, or other componentsfor manually controlling the motion of medical instrument system 200.Elongate instrument 202 may be steerable or, alternatively, the systemmay be non-steerable with no integrated mechanism for operator controlof the bending of distal end 218. In some examples, one or more lumens,through which medical instruments can be slideably deployed and used ata target anatomical location, are defined in the walls of flexible body216.

In some embodiments, medical instrument system 200 may include aflexible bronchial instrument, such as a bronchoscope or bronchialcatheter, for use in examination, diagnosis, biopsy, or treatment of alung. Medical instrument system 200 is also suited for navigation andtreatment of other tissues, via natural or surgically created connectedpassageways, in any of a variety of anatomic systems, including thecolon, the intestines, the kidneys and kidney calices, the brain, theheart, the circulatory system including vasculature, and/or the like.

In some embodiments, medical instrument system 200 may include a sealingdevice having one or more expandable bladders or balloons (not shown)located at one or more positions along the outside of flexible body 216.By injecting air, saline, and/or some other gas or fluid, the one ormore balloons may be expanded and/or collapsed to create a temporaryclosure in the passageway in which flexible body 216 is inserted. Insome examples, a shape of each of the one or more balloons uponexpanding is malleable, allowing each of the one or more balloons toconform to a shape of the passageway, to expand around other medicaldevices in the passageway, and/or the like. In some examples, each ofthe one or more balloons may optionally include a valve, flap, siphontube, and/or the like allowing evacuation of air within the passagewaydistal to the one or more balloons, thus collapsing the passagewayaround any medical instruments located distal to the one or moreballoons.

The information from tracking system 230 may be sent to a navigationsystem 232 where it is combined with information from visualizationsystem 231 and/or the preoperatively obtained models to provide theoperator or other operator with real-time position information. In someexamples, the real-time position information may be displayed on displaysystem 110 of FIG. 1 for use in the control of medical instrument system200. In some examples, control system 116 of FIG. 1 may utilize theposition information as feedback for positioning medical instrumentsystem 200. Various systems for using fiber optic sensors to registerand display a medical instrument with surgical images are provided inU.S. patent application Ser. No. 13/107,562, filed May 13, 2011,disclosing, “Medical System Providing Dynamic Registration of a Model ofan Anatomic Structure for Image-Guided Surgery,” which is incorporatedby reference herein in its entirety.

In some examples, medical instrument system 200 may be teleoperatedwithin medical system 100 of FIG. 1. In some embodiments,teleoperational manipulator assembly 102 of FIG. 1 which may includevarious handles and operator interfaces for hand-held operation of theinstrument.

FIG. 3 is a simplified diagram of medical instruments being introducedinto a patient P according to some embodiments. As shown in FIG. 3, anendotracheal (ET) tube 310 is used to introduce several medicalinstruments into the airways of patient P. In order for ET tube 310 toaccommodate more than one medical instrument, a multi-port adaptor 320is used to align the medical instruments for insertion through ET tube310. As shown, adaptor 320 includes three insertion channels 331-333 foraccepting three medical instruments 341-343. And although FIG. 3 showsonly three insertion channels 331-333 and three medical instruments341-343, one of ordinary skill that adaptor 320 may optionally includetwo channels or four or more channels. In some examples, each of themedical instruments 341-343 may be consistent with elongate instrument202 of FIG. 2. As adaptor 320 further shows, each of the channels331-333 is angled and/or curved to help direct the distal ends ofmedical instruments 341-343 into one or more lumens of a flexiblecatheter and/or ET tube 310. In some embodiments, each of the insertionchannels 331-333 may include a sealing mechanism (not shown) so as toprevent air from the lungs of patient P from flowing around each of themedical instruments 341-343.

FIGS. 4A and 4B are simplified diagrams of side views of medicalinstruments within patient anatomy according to some embodiments. Asshown in FIG. 4A, the patient anatomy includes a plurality ofpassageways 410 surrounded by tissue 412 prior to collapsing ofpassageways 410 distal to a seal point within passageways 410 as isdescribed further below. In some examples, passageways 410 maycorrespond to airways of a patient's lungs. Located within tissue 412 isa region of interest 414, which may correspond to a lesion, a tumor,and/or the like. Thus, the region of interest 414 may also be referredto herein as a lesion 414 or a tumor 414. As further shown, passageways410 are not collapsed, and have inserted into them several medicalinstruments. In some examples, one or more of the medical instrumentsmay be consistent with elongate instrument 202.

Delivery of the one or medical instruments within passageways 410 in thevicinity of lesion 414 is accomplished using an instrument catheter 420having multiple lumens including an inflation lumen 421, an evacuationlumen 422, a working lumen 423, and an imaging lumen 424. In someexamples, instrument catheter 420 is consistent with elongate instrument202. Instrument catheter 420 may be steered so as to position instrumentcatheter 420 where desired within passageways 410. In some examples, aposition sensor system (such as position sensor system 220) and/or ashape sensor (such as shape sensor 222) may be used to registerinstrument catheter 420 to one or more pre-operative or intra-operativeimages and/or models of the patient anatomy and to provide real timelocalization of instrument catheter 420 to help guide the operator insteering instrument catheter 420. In some examples, an endoscope and/orother imaging device may be inserted into instrument catheter 420through working lumen 423 and may further be used to aid the operator insteering instrument catheter 420. Once in the desired location,instrument catheter 420 may be parked.

A working catheter 430 having one or more lumens (not shown) forintroducing one or more medical instruments in proximity to lesion 414may be inserted into passageways 410 through working lumen 423. Workingcatheter 430 includes a distal end 435, which may be steered so as toorient distal end 435 toward lesion 414. In some examples, a positionsensor system (such as position sensor system 220) and/or a shape sensor(such as shape sensor 222) may be used to register working catheter 430to one or more pre-operative or intra-operative images and/or models ofthe patient anatomy and to provide real time localization of workingcatheter 430 to help guide the operator in steering distal end 435toward lesion 414. In some examples, an endoscope inserted through oneof the lumens may further be used to aid the operator in positioningand/or orienting distal end 435. A biopsy needle 437 is shown extendedbeyond distal end 435 to allow a tissue sample to be taken, although insome examples, extension of biopsy needle 437 may be delayed untildistal end 435 is properly positioned. In some examples, the endoscopeand the biopsy needle 437 may simultaneously be inserted through lumenswithin working catheter 430. Alternatively, the endoscope can be usedduring navigation through anatomy toward lesion 414 where workingcatheter 430 may be parked. The endoscope may then be removed fromworking catheter 430 and replaced with biopsy needle 437.

An imaging probe 440 having located near its distal end one or moreimaging elements 445 may be inserted into passageways 410 throughimaging lumen 424. As shown, imaging probe 440 is positioned withinpassageways 410 where it is advantageous for the one or more imagingelements 445 to take intra-operative and real-time images of lesion 414.Similar to instrument catheter 420 and working catheter 430, a positionsensor system and/or a shape sensor may be used to register imagingprobe 440 to the one or more pre-operative or intra-operative images toprovide real time localization of imaging probe 440 to help guide theoperator in positioning and/or orienting the one or more imagingelements 445 to take images of lesion 414. In some examples, the one ormore imaging elements 445 may alternatively or additionally be usable tocapture images of working catheter 430, distal end 435, biopsy needle437, and/or one or more fiducial markers located on working catheter 430and/or biopsy needle 437 to aid in registering imaging probe 440 and/orlocalizing imaging probe 440 relative to lesion 414 and/or biopsy needle437. As shown, the imaging probe 440 can include the one or more imagingelements 445 consistent with a transducer, where the imaging probe maybe rotated along a longitudinal axis of the imaging probe 440 to captureimages along an imaging field of view 447. In some examples, the one ormore imaging elements 445 may be replaced by an array of imagingelements capable of capturing images in all directions around imagingprobe 440 without having to rotate the imaging elements in the array. Inpractice, the one or more imaging elements 445 are positioned andoriented so that imaging field of view 447 passes through lesion 414 andis able to capture images of both lesion 414 and biopsy needle 437 as itpenetrates lesion 414.

Inflation lumen 421 may be used to activate a sealing device which caninclude one or more balloons 450. The one or more balloons 450 may beused to create a seal across one of passageways 410 at a seal point,prior to collapsing passageways 410 distal to the seal point. To createthe seal, the one or more balloons 450 may be expanded and/or enlargedto fill the passageway 410 at the seal point. In some examples, air,saline, and/or some other gas or fluid is injected into the one or moreballoons 450 through inflation lumen 421 to expand the one or moreballoons 450. FIG. 4B is a simplified diagram of a cut-away view of theone or more balloons 450 expanded to fill one of the passageways 410according to some embodiments. As shown in FIG. 4B, the one or moreballoons 450 are expanded until they reach the tissue 412 surroundingthe passageway 410 where they are sufficiently malleable to conform tothe shape of the tissue 412 at the seal point. FIG. 4C is a simplifieddiagram of a cross-sectional view of the passageway 410 further showingthe conformance in shape of the one or more balloons 450 about thepassageway 410.

Once passageway 410 is sealed, the passageways distal to the seal pointare allowed to collapse about working catheter 430 and imaging probe 440as shown in FIG. 4D. In some examples, an evacuation port 455 located ata distal end of evacuation lumen 422 may be used to remove air frompassageways 410 distal to the one or more balloons 450 and the sealpoint. In some examples, a vacuum may be applied to evacuation lumen 422to siphon air from passageways 410. In some examples, one or morevalves, flaps, and/or the like (not shown) may be located at or nearevacuation port 455 and/or along evacuation lumen 422 to aid in thesiphoning of the air.

FIG. 5 is a simplified diagram of side views of medical instrumentswithin patient anatomy according to some embodiments. As shown in FIG.5, imaging probe 440 of FIGS. 4A and 4D is placed in a different branchof passageway 410 than working catheter 430. As long as the one or moreimaging elements 445 are within range of lesion 414, are positionableand orientable to capture images of lesion 414, and are located distalto the one or more balloons 450, any combination of passageways may beused.

FIG. 6 is a simplified diagram of side views of medical instrumentswithin patient anatomy according to some embodiments. As shown in FIG.6, imaging probe 440 of FIGS. 4A and 4B is replaced in favor of animaging probe 610 equipped with an imaging needle 630. Similar toworking catheter 430, imaging probe 610 includes a distal end 620, whichmay be steered so as to orient distal end 620 toward or slightly to theside of lesion 414. In some examples, a position sensor system (such asposition sensor system 220) and/or a shape sensor (such as shape sensor222) may be used to register imaging probe 610 to one or morepre-operative or intra-operative images and/or models of the patientanatomy to guide the operator in steering distal end 620 toward lesion414. Imaging probe 610 further includes imaging needle 630, which may bemounted and/or deployed from distal end 620. Imaging needle 630 includesone or more imaging elements 635 usable to capture images of lesion 415,tissue 412, biopsy needle 437, and/or the like. In some examples, theone or more imaging elements are consistent with one or more EBUStransducers that may be rotated within imaging needle 630 to captureimages along an imaging field of view 637. In practice, the one or moreimaging elements 635 are positioned and oriented so that imaging fieldof view 637 passes through lesion 414 and is able to capture images ofboth lesion 414 and biopsy needle 437 as it penetrates lesion 414.Imaging probe 610 is advantageous over imaging probe 440 in that imagingneedle 630 is capable of being inserted into tissue 412 and/or lesion414 allowing for a more options when planning where to place the one ormore imaging elements 635 so as to guide placement of biopsy needle 437.In some examples, because imaging needle 630 is inserted within tissue412 at or near lesion 414, it may be possible to obtain images tosupport a procedure without having to collapse or fully collapsepassageways 410. In some examples, extension of imaging needle 630 maybe delayed until distal end 620 is positioned near lesion 414 andpassageways 410 are collapsed. In some examples, imaging needle 630 maybe surrounded by a sleeve (not shown) so that imaging needle 630 may berotated after being inserted into tissue 412 without additionallydisrupting and/or damaging tissue 412. In some examples, the sleeve maybe extended after imaging needle 630 is inserted into tissue 412.

As discussed above and further emphasized here, FIG. 6 is merely anexample which should not unduly limit the scope of the claims. One ofordinary skill in the art would recognize many variations, alternatives,and modifications. In some embodiments, imaging probe 610 and imagingneedle 630 may optionally be deployed through a lumen within workingcatheter 430. In some embodiments, biopsy needle 437 may be omitted whenimaging needle 630 is further configured to take a tissue sample.

As discussed above and further emphasized here, FIGS. 4A-6 are merelyexamples which should not unduly limit the scope of the claims. One ofordinary skill in the art would recognize many variations, alternatives,and modifications. In some embodiments, different configurations of themedical instruments are possible. In some examples, biopsy needle 437may be replaced by other biopsy instruments, ablation devices,cryotherapeutic devices, drug delivery needles, and/or other surgical,diagnostic, or therapeutic tools. In some examples, ultrasoundtransducers such as side-facing, forward-facing transducers, curvedtransducers, radial transducers, and/or the like may be used for the oneor more imaging elements 445. In some examples, the one or more balloons450 may be replaced by a series of balloons located at different pointsalong instrument catheter 420 to create a series of seal points withinthe sealed passageway 410. In some examples, the one or more balloons450 may include multiple side-by-side balloons that each enlarge toclose off a portion of passageway 410 at the seal point. In someexamples, the one or more balloons 450 may be mounted on a sleeve aroundthe outside of instrument catheter 420.

In some embodiments, either of working lumen 423 and/or imaging lumen424 may optionally be omitted and replaced by a combined lumen. When thecombined lumen is used, both working catheter 430 and imaging probe 440may be deployed into passageways 410 via the combined lumen,

In some embodiments, evacuation lumen 422 with evacuation port 455 maybe omitted and replaced by other mechanisms to remove air from thepassageways. In some examples, one or more open lumens in workingcatheter 430 and/or imaging probe 440 may include a proximal vacuumwhich can be used to aid in siphoning of passageways 410 during airwaycollapse. In some examples, the one or more balloons 450 may optionallyinclude one or more flaps and/or value structures to allow air to beremoved distal to the seal point.

In some embodiments, one of the instrument catheter 420, workingcatheter 430, and imaging probe 440 includes a position sensor system(such as position sensor system 220). The working catheter 430 andimaging probe 440 are received in lumens within the instrument catheter420 so the relative positions of the instrument catheter 420, workingcatheter 430, and imaging probe 440 can be determined based on theconstruction of instrument catheter 420 and known or measured insertiondistances (e.g., using sensors or gauges at the proximal end of thedevices to measure insertion) of the working catheter 430 and imagingprobe 440 relative to the instrument catheter 420.

In some examples, the working catheter 430 may include a position sensorsystem (such as position sensor system 220) to register the workingcatheter 430 to one or more pre-operative or intra-operative imagesand/or models of the patient anatomy. The working catheter 430 may bereceived and positioned within the working lumen 423 of the instrumentcatheter with a distal end 435 of the working catheter 430 flush to,near or proximal to a distal end of the instrument catheter 420 prior toinsertion of the instrument catheter 420 within passageways 410. Theinstrument catheter 420 and working catheter 430 can be steered as anassembly to position the distal end of the instrument catheter at theseal point. The position sensor system within the working catheter 430can provide real time localization of both the working catheter 430 andinstrument catheter 420 to help guide the operator in steering thedistal end of the instrument catheter.

Instrument catheter 420 can be parked at the seal point at a knownlocation as measured by the position sensor system then working catheter430 may be inserted beyond the distal end of instrument catheter 420.The position sensor system within working catheter 430 can provide realtime localization of working catheter 430 to help guide the operator insteering distal end 435 of working catheter 430 in closer proximity tolesion 414. The position of imaging probe 440 can be determined based onconstruction of instrument catheter 420 and known or measured insertiondistances of imaging probe 440. Thus imaging probe 440 can also besteered through imaging lumen 424 and positioned at a location where itis advantageous for the one or more imaging elements 445 to takeintra-operative and real time images of lesion 414. It should beunderstood that while in this example only working catheter 430 includesa sensor position system 220, position sensor system 220 can be includedin working catheter 430, instrument catheter 420, and imaging probe 440or within any combination of devices while the relative position of adevice without a position sensor system may be determined by theconstruction of instrument catheter 420 and measured/calculatedinsertion of the device (e.g., using sensors or gauges at the proximalend of the devices).

In alternate embodiments to FIGS. 4A-6, FIGS. 7A and 7B show simplifieddiagrams of side views of medical instruments within patient anatomywhere instrument catheter 420 is replaced in favor of three separateprobes including a flexible catheter 720, an imaging probe 740, and aballoon catheter or sealing probe 750. As shown in FIG. 7A, the patientanatomy includes a plurality of passageways 710 surrounded by tissue 712prior to collapsing of passageways 710 distal to a seal point withinpassageways 710 as is described further below. In some examples,passageways 710 may correspond to airways of a patient's lungs. Locatedwithin tissue 712 is a region of interest 714, which may correspond to alesion, a tumor, and/or the like. Thus, region of interest 714 may alsobe referred to herein as a lesion 714 or a tumor 714. As further shown,passageways 710 are not collapsed, and have inserted into them severalmedical instruments. In some examples, each of the medical instrumentsmay be consistent with elongate instrument 202.

Flexible catheter 720 includes one or more lumens (not shown) forintroducing one or more medical instruments in proximity to lesion 714.Flexible catheter 720 includes a distal end 725, which may be steered soas to orient distal end 725 toward lesion 714. In some examples, aposition sensor system (such as position sensor system 220) and/or ashape sensor (such as shape sensor 222) may be used to register flexiblecatheter 720 to one or more pre-operative or intra-operative imagesand/or models of the patient anatomy and to provide real timelocalization of the flexible catheter 720 to help guide the operator insteering distal end 725 toward lesion 714. In some examples, anendoscope inserted through one of the lumens may further be used to aidthe operator in positioning and/or orienting distal end 725. A biopsyneedle 730 is shown extended beyond distal end 725 to allow a tissuesample to be taken, although in some examples, extension of biopsyneedle 730 may be delayed until distal end 725 is properly positioned.In some examples, the endoscope and the biopsy needle 730 maysimultaneously be inserted through lumens within catheter 720.Alternatively, the endoscope can be used during navigation throughanatomy to the region of interest 714 where the catheter 720 may beparked. The endoscope may then be removed from catheter 720 and replacedwith the biopsy needle 730.

Imaging probe 740 includes one or more imaging elements 745 located nearits distal end. As shown, imaging probe 740 is located withinpassageways 710 where it is advantageous for the one or more imagingelements 745 to take intra-operative and real-time images of lesion 714.Similar to flexible catheter 720, a position sensor system and/or ashape sensor may be used to register imaging probe 740 to the one ormore pre-operative or intra-operative images to provide real timelocalization of the imaging probe 740 to help guide the operator inpositioning and/or orienting the one or more imaging elements 745 totake images of lesion 714. In some examples, the one or more imagingelements 745 may alternatively or additionally be usable to captureimages of flexible catheter 720, imaging probe 740, distal end 725,biopsy needle 730, and/or one or more fiducial markers located onflexible catheter 720 and/or biopsy needle 730 to further aid inregistering the images captured by imaging probe 740 and/or localizingimaging probe 740 relative to lesion 714 and/or biopsy needle 730. Asshown, the one or more imaging elements 745 are consistent with one ormore transducers that may be rotated, by rotating imaging probe 740, tocapture images in an imaging field of view 747 directed toward lesion714. In practice, the one or more imaging elements 745 are positionedand oriented so that imaging field of view 747 passes through lesion 714and is able to capture images of both lesion 714 and biopsy needle 730as it penetrates lesion 714. In some embodiments, the one or moreimaging elements 745 may be replaced by an array of imaging elementscapable of capturing images in all directions around imaging probe 740without having to rotate the imaging elements in the array.

Sealing probe 750 may be used to create a seal across one of passageways710, prior to collapsing passageways 710 distal to the seal point. Tocreate the seal, sealing probe 750 includes one or more balloons 755,which may be expanded and/or enlarged to fill the passageway 710 at theseal point and to conform around flexible catheter 720 and/or imagingprobe 740. In some examples, air, saline, and/or some other gas or fluidis injected into the one or more balloons 755 through one or more lumensin sealing probe 750 to expand the one or more balloons 755. FIG. 7C isa simplified diagram of a cut-away view of the one or more balloons 755expanded to fill one of the passageways 710 according to someembodiments. As shown in FIG. 7C, the one or more balloons 755 areexpanded until they reach the tissue 712 surrounding the passageway 710where they are sufficiently malleable to conform to the shape of thetissue 712 at the seal point. Additionally, the one or more balloons 755are capable of conforming in shape about flexible catheter 720 andimaging probe 740 to effectively seal the passageway 710. FIG. 7D is asimplified diagram of a cross-sectional view of the passageway 710further showing the conformance in shape of the one or more balloons 755about the passageway 710 as well as flexible catheter 720 and imagingprobe 740. FIG. 7E is a simplified diagram of a cross-sectional view ofalternate embodiments of the one or more balloons 755 where flexiblecatheter 720 and imaging probe 740 are inserted through a port 760 inthe one or more balloons 755. In some examples, port 760 may optionallyinclude one or more flaps and/or value structures to support sealingaround flexible catheter 720 and/or imaging probe 740 when the one ormore balloons 755 are expanded.

Once passageway 710 is sealed, the passageways 710 distal to the sealpoint are allowed to collapse about flexible catheter 720 and imagingprobe 740 as shown in FIG. 7B. In some examples, the air withinpassageways 710 is removed by operating one or more flaps or valves (notshown) in the one or more balloons 755 and/or by siphoning the air outof passageways 710 through a lumen in flexible catheter 720, imagingprobe 740, and/or sealing probe 750.

As discussed above and further emphasized here, FIGS. 7A-7E are merelyexamples which should not unduly limit the scope of the claims. One ofordinary skill in the art would recognize many variations, alternatives,and modifications. In some embodiments, different configurations of themedical instruments are possible. In some examples, biopsy needle 730may be replaced by other biopsy instruments, ablation devices,cryotherapeutic devices, drug delivery needles, and/or other surgical,diagnostic, or therapeutic tools. In some examples, ultrasoundtransducers such as side-facing, forward-facing transducers, curvedtransducers, radial transducers, and/or the like may be used for the oneor more imaging elements 745. In some examples, the one or more balloons755 may be replaced by a series of balloons located at different pointsalong sealing probe 750 to create a series of seal points within thesealed passageway 710. In some examples, the one or more balloons 755may include multiple side-by-side balloons that each enlarge to closeoff a portion of passageway 710 at the seal point.

In some embodiments, imaging probe 740 may be inserted into differentpassageways 710 than flexible catheter 720 in much the same manner asshown in the embodiments of FIG. 5. As long as the one or more imagingelements 745 are within range of lesion 714, are positionable andorientable to capture images of lesion 714, and are located distal tothe one or more balloons 755 any combination of passageways may be used.

In some embodiments, the structures and/or functionalities of flexiblecatheter 720, imaging probe 740, and/or sealing probe 750 may becombined so that they are deployable in the passageways using two orfewer elongate instrument bodies. In some examples, imaging probe 740and the one or more imaging elements 745 may be deployed within a lumenwithin flexible catheter 720 and then extended and/or retracted withinthe lumen to position and orient the one or more imaging elements 745relative to lesion 714. In some examples, imaging probe 740 and the oneor more imaging elements 745 may be inserted through a lumen of flexiblecatheter 720 that has a side port located somewhere along the elongatedbody of flexible catheter 720, thus allowing the one or more imagingelements 745 to be deployed outside of flexible catheter. In someexamples, an imaging transducer may be integrated onto the exterior offlexible catheter 720. In some examples, sealing probe 750 may similarlybe inserted through a lumen of flexible catheter 720 that has a sideport located along somewhere along the elongated body of flexiblecatheter 720 allowing the one or more balloons 755 to be deployedoutside flexible catheter 720. In some examples, a separate sealingprobe 750 is omitted and the one or more balloons 755 may be mounted tothe exterior of flexible catheter 720 and/or imaging probe 740 with oneor more lumens provided in flexible catheter 720 and/or imaging probe740 to provide the gas or fluid used to expand the one or more balloons755. In some examples, the one or more balloons 755 and the one or moregas or fluid lumens may be mounted on a sheath that surrounds flexiblecatheter 720 and/or imaging probe 740. In some examples, flexiblecatheter 720 carries a biopsy needle with an open lumen. The open lumenmay include a proximal vacuum which can be used to aid in siphoning ofpassageways 710 during airway collapse.

In some examples, an adaptor (such as adaptor 320 having insertionchannels 331-333 for accepting medical instruments) may be used toinsert the instrument catheter 720, biopsy needle 730, and/or imagingprobe 740 into one or more passageways, such as the airways of lungs ofa patient. With known construction of adaptor 320 and relative knownpositions of insertion channels 331-333, the relative radial positionsof instrument catheter 720, biopsy needle 730, and/or imaging probe 740could be determined relative to one another. Relative insertion of eachof instrument catheter 720, biopsy needle 730, and/or imaging probe 740could be measured/calculated using sensors or gauges at the proximal endof the instruments. A position sensor system (such as position sensorsystem 220) can be included within any one of the devices such as biopsyneedle 730, instrument catheter 720, imaging probe 740, or within anycombination of the three devices giving the position, orientation,and/or pose of the device in a fixed coordinate system (such as apatient coordinate system). With known relative position of devices toone another based on adaptor 320 and measured/calculated insertions, theposition of biopsy needle 730, instrument catheter 720, and/or imagingprobe 740 can each be determined.

FIG. 8 is a simplified diagram of a method 800 of performing a procedureusing integrated real-time imaging according to some embodiments. One ormore of the processes 805-870 of method 800 may be implemented, at leastin part, in the form of executable code stored on non-transient,tangible, machine readable media that when run by one or more processors(e.g., one or more processors of control system 112) may cause the oneor more processors to perform one or more of the processes 805-875. Insome embodiments, method 800 is usable to manipulate one or more medicalinstruments, such as any of the instruments discussed above with respectto FIGS. 2, and/or 4A-6, to perform a procedure where integratedreal-time imaging of target anatomy, such as lesion 414 is desirable.The ordering of processes 805-870 in FIG. 8 is exemplary only and otherpossible orderings and/or arrangements of processes 805-870 arepossible. In some examples, one or more of processes 805-870 may beperformed concurrently. In some examples, processes 855-865 may beperformed concurrently so that real-time images obtained by the imagingprobe may be continuously obtained to locate the target anatomy and tomonitor whether a medical tool is properly deployed to the targetanatomy. In some embodiments, other processes not shown in FIG. 8 mayalso be part of method 800.

At a process 805, one or more pre-operative images are obtained of atarget anatomy. Using any suitable imaging technology, such as CT, MM,fluoroscopy, thermography, ultrasound, OCT, thermal imaging, impedanceimaging, laser imaging, nanotube X-ray imaging, and/or the like, imagedata is obtained. This pre-operative image data is processed to generateone or more two-dimensional, three-dimensional, or four-dimensional(including e.g., time based or velocity based information) images. Insome examples, the images may further be processed to create one ormodels of the target anatomy, including locations and orientations ofpassageways usable to reach the target anatomy. In some examples, thetarget anatomy may correspond to a tumor or lesion, such as lesion 414.In some examples, the one or more images and/or one or more models mayfurther account for a phase of anatomic motion (e.g., respiration, heartactivity, and/or the like) in order to better model changes within thetarget anatomy and/or the passageways due to the anatomic motion.

At a process 810, a procedure is planned using the one or more imagesand/or the one or more models obtained during process 805. Elements ofthe plan include determining paths through the passageways for each ofthe medical instruments including, for example, instrument catheter 420,imaging probe 440 and/or 610, and/or working catheter 430. Additionalelements of the plan include determining target locations forpositioning and orienting each of the medical instruments for itsintended task. In some examples, this includes determining where toposition and orient the distal end of a working catheter, such as distalend 435 of working catheter 430, so that a medical tool, such as biopsyneedle 437, can be deployed for use on the target anatomy. This furtherincludes determining where to position and orient the one or moreimaging elements, such as the one or more imaging elements 445 ofimaging probe 440 and/or the one or more imaging elements 635 of imagingneedle 630, so that an imaging field of view, such as imaging field ofview 447 and/or 637, is able to capture real-time intraoperative imagesof the target anatomy as well as the medical tool being deployed usingthe working catheter. In some examples, a desired imaging field of viewincludes an image of the working catheter. Alternatively, the desiredimaging field of view is obtained by positioning the imaging probedirectly adjacent a passageway wall containing the target anatomy.Elements of the plan can additionally include determining where toposition and orient one or more sealing balloons, such as the one ormore balloons 450, so that the passageways contain the one or moreimaging elements and the distal end of the working catheter, such asworking catheter 430, may be collapsed as desired during the procedure.

At a process 815, the instrument catheter is inserted into thepassageways. Using, for example, adaptor 320 and/or ET tube 310, theinstrument catheter is inserted into one or more passageways, such asthe airways of the lungs of patient P (corresponding to passageways410). In some examples, navigation of the instrument catheter within thepassageways may be aided by an imaging device, such as an endoscope,providing images from the distal end of the instrument catheter.

At a process 820, the instrument catheter is registered to thepreoperative images and/or models obtained during process 805. As theinstrument catheter is inserted into and moved around the passageways,position and orientation for the instrument catheter and the distal endof the instrument catheter are gathered using, for example, shape sensor222 and/or position sensor system 220. As this position and orientationdata is collected, it is correlated with the similar position andorientation data on the passageways determined using the one or moremodels obtained during process 805. Once sufficient position andorientation data for the instrument catheter and/or the distal end areobtained, a registration transform is developed that maps position andorientation data obtained for the instrument catheter and the distal endinto the models obtained during process 805. This registration transformis typically suitable to address position, scaling, and/or orientationdifferences between the actual patient anatomy navigated by the workingcatheter and the distal end and the model data for the same patientanatomy obtained during process 805. For example U.S. patent applicationSer. No. 13/107,562 (filed May 13, 2011) (disclosing “Medical SystemProviding Dynamic Registration of a Model of an Anatomic Structure forImage-Guided Surgery”) which is incorporated by reference herein in itsentirety, discloses several approaches for performing such aregistration. In some examples, the shape sensor and/or the positiondetection system may further be used to develop a kinematic model thattracks the position and orientation of the distal end relative to aproximal end of the instrument catheter. In some examples, the proximalend may correspond to a known point on adaptor 320 and/or a pointassociated with an actuator used to insert and/or retract the instrumentcatheter within the passageways.

At a process 825, the instrument catheter is driven to a seal pointusing the one or more plans determined during process 810 and theregistration of process 820. As the instrument catheter is driven,additional position and orientation data obtained using the shape sensorand/or position sensing system may be used to continually monitor theposition and orientation of the distal end of the instrument catheterrelative to the passageways and the target anatomy. In some examples,navigation of the instrument catheter within the passageways may beaided by an imaging device, such as an endoscope, providing images fromthe distal end of the instrument catheter. In some examples, informationfrom the one or more plans obtained during process 810 may be used toprovide guidance to the operator using haptic feedback and/or a displaysystem, such as display system 110, by providing directional hints,virtual overlays, and/or the like.

At a process 830, the instrument catheter is oriented and then parked.When the distal end of the instrument catheter is positioned at the sealpoint determined during the planning of process 810, the distal end ofthe instrument catheter is oriented to align the distal end of theinstrument catheter with the passageways at the seal point. As theinstrument catheter is oriented, additional position and orientationdata obtained using the shape sensor and/or position sensing system maybe used to continually monitor the position and orientation of theinstrument catheter relative to passageways and the target anatomy. Insome examples, position and orientation data using the shape sensingand/or positioning sensing of the working catheter can be used in placeof or in addition to known relative positions of the working catheter inrelation to the imaging probe. In some examples, the instrument cathetermay be further rotated based on the cross-sectional shape of thepassageways at the seal point to align one or more pre-shaped balloonswith the cross-sectional shape. In some examples, the instrumentcatheter can additionally or alternatively be rotated in order toprovide positioning of the imaging probe as it exits the distal end ofthe instrument catheter to an orientation in relation the target anatomywhich achieves the desired imaging field of view. Once the instrumentcatheter is oriented, it is parked. The parking positions the instrumentcatheter within the passageways so that it is not further insertedand/or retracted within the passageways. In some examples, a stiffnessof the instrument catheter may further be increased so that theinstrument catheter is further held in position within the passageways.

At a process 835, an imaging probe, such as imaging probe 440 and/orimaging probe 610, is inserted into the passageways through a lumen,such as imaging lumen 424, within the instrument catheter and thendriven toward the imaging position. In some examples, imaging probe maybe inserted into the lumen of the instrument catheter before process 815and then extended beyond the distal end of the instrument catheterduring process 835. Using processes similar to processes 815-830, theimaging probe is inserted into the passageways, registered to the one ormore models obtained during process 805, and driven toward the imagingposition according to the plan determined during process 810. In someexamples, information from the one or more plans obtained during process810 may be used to provide guidance to the operator using hapticfeedback and/or a display system, such as display system 110, byproviding directional hints, virtual overlays, and/or the like.Registration of the imaging probe can be obtained using position andorientation information obtained by the shape sensor 222 and/or positionsensor system 220 integrated within the imaging probe. Alternatively,imaging probe position and orientation can be known relative to a fixedrelative position to the instrument catheter based on instrumentcatheter construction and/or relative position of the imaging probe tothe working catheter. For example, the imaging probe will be receivedwithin a lumen within the instrument catheter and the relative positionof the lumen will be known based on the construction of the catheter.The insertion of the imaging probe can be determined based on sensorsand/or gauges at a proximal end of the imaging probe. In some examples,insertion of the imaging probe can be determined using images from theendoscope providing images from the distal end of the instrument.

The imaging probe and the one or more imaging elements are furtheroriented so that an imaging field of view, such as imaging field of view447 and/or 637, is likely to be able to obtain images of the targetanatomy and the medical tool deployed using a working catheter. In someexamples, the one or more imaging elements may also be localizedrelative to the target anatomy and/or the distal end of the instrumentcatheter and/or the distal end of the working catheter. Localizing theone or more imaging elements to the target anatomy and/or the distal endof the instrument catheter allows positions of the target anatomy, thedistal end of the instrument catheter, and/or the medical tool deployedat the distal end of the working catheter observed within the imagesobtained by the one or more imaging elements to be more easily mapped tomovements and/or adjustments to the distal end of the working catheterand/or the medical tool so that the medical tool may be deployed withinthe target anatomy. In some examples, the localizing may be obtained bycombining the registration transform of the instrument catheter and/orthe working catheter with the registration transform of the imagingprobe through a common reference point, such as a point on adaptor 320.In some examples, the localizing may further include continuedmonitoring of the positions and orientations of the working catheterand/or the imaging probe using respective shape sensors and/or positionsensor systems and/or localization information obtainable using imagesof the working catheter, the distal end of the working catheter, and/orthe medical tool obtained using the one or more imaging elements. Insome examples, one or more fiducial markers, such as emitters and/orspecial markers, mounted to known locations on the working catheter, thedistal end of the working catheter, and/or the medical tool may alsocontribute to the localization.

At a process 840, the working catheter, such as working catheter 430, isinserted into the passageways through a lumen, such as working lumen423, within the instrument catheter and then driven toward the targetanatomy according to the plan determined in process 810. In someexamples, information from the one or more plans obtained during process810 may be used to provide guidance to the operator using hapticfeedback and/or a display system, such as display system 110, byproviding directional hints, virtual overlays, and/or the like. In someexamples, working catheter may be inserted into the lumen of theinstrument catheter before process 815 and then extended beyond thedistal end of the instrument catheter during process 840. Usingprocesses similar to processes 815-830 and/or 835, the working catheteris inserted into the passageways, registered to the one or more modelsobtained during process 805, and driven toward the target anatomy. Insome examples, movement of the distal end of the working catheter may befurther guided using an endoscope inserted through a lumen in theworking catheter. In some examples, the distal end of the workingcatheter may also be localized relative to the target anatomy and/or theimaging probe. In some examples, the localizing may be obtained bycombining the registration transform of the instrument catheter and/orthe instrument probe with the registration transform of the workingcatheter through a common reference point, such as a point on adaptor320. In some examples, the localizing may further include continuedmonitoring of the positions and orientations of the working catheterand/or the imaging probe using respective shape sensors and/or positionsensor systems and/or localization information obtainable using imagesof the working catheter, the distal end of the working catheter, and/orthe medical tool obtained using the one or more imaging elements of theimaging probe. In some examples, one or more fiducial markers, such asemitters and/or special markers, mounted to known locations on theworking catheter, the distal end of the working catheter, and/or themedical tool may also contribute to the localization.

At a process 845, the passageway is closed at the seal point byenlarging the one or more sealing balloons located at the distal end ofthe instrument catheter. The one or more balloons may be enlarged byinjecting air, saline, and/or some other gas or fluid into the one ormore sealing balloons using one or more lumens, such as inflation lumen421 within the instrument catheter so that the one or more sealingballoons fill the passageway at the seal point, and conform to the shapeof the passageway at the seal point.

At a process 850, one or more passageways distal to the seal point arecollapsed. In some examples, air within the one or more passagewaysdistal to the seal point is removed by vacuuming or siphoning it throughan evacuation port, such as evacuation port 455 of evacuation lumen 422.In some examples, the air within the one or more passageways mayoptionally be siphoned from the one or more passageways using one ormore lumens in the sealing probe, the imaging, probe, the workingcatheter, and/or a device carried within the working catheter such as abiopsy needle with an open lumen.

At a process 855, the imaging probe is adjusted to obtain images of thetarget anatomy. Because the positioning and/or orienting of the one ormore imaging elements during process 835 may be inaccurate and/or thepositioning and/or orienting may be disturbed as the one or morepassageways distal to the seal point are collapsed, the imaging probeand the one or more imaging elements may be adjusted to align theimaging field of view with the target anatomy. In some examples, theimages are obtained and used to aid in adjustment of the imaging probesuch that the imaging probe is inserted or retracted in the passagewaysand rotated until the target anatomy is in view. In some examples,position and/or orientation data from the shape sensor or positionsensor system may be used to aid the adjustment of the imaging probe. Insome examples, guidance for adjusting the imaging probe, such as hapticfeedback and/or direction hints, virtual overlays, and/or the like, maybe provided to the operator using a display system, such as displaysystem 110.

At a process 860, an image is obtained using the one or more imagingelements of the imaging probe. In some examples, when the one or moreimaging elements include one or more transducers, the image may beobtained by rotating the imaging probe to obtain a planar slice aroundthe imaging probe that is aligned with an imaging field of view, such asimaging field of view 447 and/or 637, and/or oriented with the targetanatomy. The obtained image is then analyzed to determine a location ofthe target anatomy relative to the imaging probe.

At a process 865, the medical tool is driven to the target anatomy byadjusting the working catheter and/or by deploying the medical toolrelative to the distal end of the working catheter. In some examples,the image obtained during process 860 along with the localizationdetermined during processes 835 and/or 840 may be used to adjust theposition of the working catheter and/or the distal end of the workingcatheter relative to the target anatomy. In some examples, when themedical tool is biopsy needle 437, biopsy needle 437 may be driven byextending it into the target anatomy where it may be captured within theimage obtained during process 860. In some examples, the medical toolmay be consistent with other biopsy instruments, ablation devices,cryotherapeutic devices, drug delivery needles, and/or other surgical,diagnostic, or therapeutic tools. In some examples, when the imageobtained during process 860 does not include the target anatomy, process860 may be omitted until a real-time image of the target anatomy isobtained by the imaging probe. Processes 855-865 may then be repeated tocontinually adjust the imaging probe, obtain images, and drive themedical tool so as to provide real-time monitoring of the procedurebeing performed using the medical tool.

At a process 870, the one or more passageways collapsed during process850 are re-inflated. In some examples, the one or more passageways maybe re-inflated by deflating the one or more balloons by opening the oneor more flaps and/or the one or more valves located on the one or moreballoons and allowing the passageways to re-inflate naturally as thepatient is breathing. In some examples, the one or more passageways maybe re-inflated by re-introducing air or another suitable gas into theone or more passageways using the one or more lumens in the workingcatheter, the imaging probe, and/or the sealing probe used to collapsethe one or more passageways during process 850.

In some examples, when processes 855-865 are not able to complete theprocedure, process 870 may include partially re-inflating the one ormore passageways so that the imaging probe and/or the working cathetermay be repositioned and/or reoriented (e.g., by performing processes 855and/or 865 while the one or more passageways are partially re-inflated)before re-collapsing the one or more passageways by returning to process850. In some examples, the partial re-inflation of the one or morepassageways allows for more movement in the imaging probe and/or theworking catheter because the partially collapsed one or more passagewaysdo not impede movement of the imaging probe and/or the working catheteras much as the fully collapsed one or more passageways.

FIG. 9 is a simplified diagram of a method 900 of performing a procedureusing integrated real-time imaging according to some additionalembodiments. One or more of the processes 905-965 of method 900 may beimplemented, at least in part, in the form of executable code stored onnon-transient, tangible, machine readable media that when run by one ormore processors (e.g., one or more processors of control system 112) maycause the one or more processors to perform one or more of the processes905-965. In some embodiments, method 900 is usable to manipulate one ormore medical instruments, such as any of the instruments discussed abovewith respect to FIGS. 2 and/or 7A-7E, to perform a procedure whereintegrated real-time imaging of target anatomy, such as lesion 714 isdesirable. The ordering of processes 905-965 in FIG. 9 is exemplary onlyand other possible orderings and/or arrangements of processes 905-965are possible. In some examples, processes 920-735 may be performed inother orders and/or any two or more may be performed concurrently. Insome embodiments, process 935 may be performed prior to processes915-930 so that a flexible catheter and/or an imaging probe may beinserted through one or more ports, such as port 760 after one or moreballoons used for sealing are deployed within the passageways. In someexamples, processes 950-960 may be performed concurrently so thatreal-time images obtained by the imaging probe may be continuouslyobtained to locate the target anatomy and to monitor whether a medicaltool is properly deployed to the target anatomy. In some embodiments,other processes not shown in FIG. 9 may also be part of method 900.

At a process 905, one or more pre-operative images are obtained of atarget anatomy. Using any suitable imaging technology, such as CT, MM,fluoroscopy, thermography, ultrasound, OCT, thermal imaging, impedanceimaging, laser imaging, nanotube X-ray imaging, and/or the like, imagedata is obtained. This pre-operative image data is processed to generateone or more two-dimensional, three-dimensional, or four-dimensional(including e.g., time based or velocity based information) images. Insome examples, the images may further be processed to create one ormodels of the target anatomy, including locations and orientations ofpassageways usable to reach the target anatomy. In some examples, thetarget anatomy may correspond to a tumor or lesion, such as lesion 414.In some examples, the one or more images and/or one or more models mayfurther account for a phase of anatomic motion (e.g., respiration, heartactivity, and/or the like) in order to better model changes within thetarget anatomy and/or the passageways due to the anatomic motion.

At a process 910, a procedure is planned using the one or more imagesand/or the one or more models obtained during process 905. Elements ofthe plan include determining paths through the passageways for each ofthe medical instruments including, for example, flexible catheter 720,imaging probe 740, and/or sealing probe 750. Additional elements of theplan include determining target locations for positioning and orientingeach of the medical instruments for its intended task. In some examples,this includes determining where to position and orient the distal end ofa flexible catheter, such as distal end 725 of flexible catheter 720, sothat a medical tool, such as biopsy needle 730, can be deployed for useon the target anatomy. This further includes determining where toposition and orient the one or more imaging elements, such as the one ormore imaging elements 745 of imaging probe 740 and/or the one or moreimaging elements 635 of imaging needle 630, so that an imaging field ofview, such as imaging field of view 447 and/or 637, is able to capturereal-time intraoperative images of the target anatomy as well as themedical tool being deployed using the flexible catheter. In someexamples, a desired imaging field of view includes an image of theflexible catheter. Alternatively, the desired imaging field of view isobtained by positioning the imaging probe directly adjacent a passagewaywall containing the target anatomy. Elements of the plan canadditionally include determining where to position and orient one ormore sealing balloons, such as the one or more balloons 755 of sealingprobe 750, so that the passageways contain the one or more imagingelements and the distal end of the flexible catheter, such as flexiblecatheter 420, may be collapsed as desired during the procedure.

At a process 915, the flexible catheter is inserted into thepassageways. Using, for example, adaptor 320 and/or ET tube 310, theflexible catheter is inserted into one or more passageways, such as theairways of the lungs of patient P (corresponding to passageways 710),and is navigated by the operator. In some examples, navigation of theflexible catheter within the passageways may be aided by an imagingdevice, such as an endoscope, providing images from the distal end.

At a process 920, the flexible catheter is registered to thepreoperative images and/or models obtained during process 905. As theflexible catheter is inserted into and moved around the passageways,position and orientation for the flexible catheter and the distal endare gathered using, for example, shape sensor 222 and/or position sensorsystem 220. As this position and orientation data is collected, it iscorrelated with the similar position and orientation data on thepassageways determined using the one or more models obtained duringprocess 905. Once sufficient position and orientation data for theflexible catheter and/or the distal end are obtained, a registrationtransform is developed that maps position and orientation data obtainedfor the flexible catheter and the distal end into the models obtainedduring process 905. This registration transform is typically suitable toaddress position, scaling, and/or orientation differences between theactual patient anatomy navigated by the flexible catheter and the distalend and the model data for the same patient anatomy obtained duringprocess 905. For example U.S. patent application Ser. No. 13/107,562(filed May 13, 2011) (disclosing “Medical System Providing DynamicRegistration of a Model of an Anatomic Structure for Image-GuidedSurgery”) which is incorporated by reference herein in its entirety,discloses several approaches for performing such a registration. In someexamples, the shape sensor and/or the position detection system mayfurther be used to develop a kinematic model that tracks the positionand orientation of the distal end relative to a proximal end of theflexible catheter. In some examples, the proximal end may correspond toa known point on adaptor 320 and/or a point associated with an actuatorused to insert and/or retract the flexible catheter within thepassageways.

At a process 925, the flexible catheter is driven toward the targetanatomy using the one or more plans determined during process 910 andthe registration of process 920. As the flexible catheter is driven,additional position and orientation data obtained using the shape sensorand/or position sensing system may be used to continually monitor theposition and orientation of the distal end of the flexible catheterrelative to the passageways and the target anatomy. In some examples,navigation of the flexible catheter within the passageways may be aidedby an imaging device, such as an endoscope, providing images from thedistal end of the flexible catheter. When the distal end of the flexiblecatheter is positioned sufficiently near and oriented toward the targetanatomy, a medical tool, such as biopsy needle 730, may be used toaccess the target anatomy. In some examples, information from the one ormore plans obtained during process 910 may be used to provide guidanceto the operator using haptic feedback and/or a display system, such asdisplay system 110, by providing directional hints, virtual overlays,and/or the like.

At a process 930, an imaging probe, such as imaging probe 740 and/orimaging probe 610, is inserted and driven toward the imaging position.Using processes similar to processes 915-925, the imaging probe isinserted into the passageways, registered to the one or more modelsobtained during process 905, and driven toward the imaging point usingthe one or more plans determined during process 910. The imaging probeand the one or more imaging elements are further oriented so that animaging field of view, such as imaging field of view 747 and/or 637, islikely to be able to obtain images of the target anatomy and the medicaltool deployed using the flexible catheter. In some examples, the one ormore imaging elements may also be localized relative to the targetanatomy and/or the distal end of the flexible catheter. Localization ofthe imaging probe can be obtained using position and orientationinformation obtained by the shape sensor and/or position sensor systemintegrated within the imaging probe. Alternatively, imaging probeposition and orientation can be known relative to a position on theflexible catheter based on flexible catheter and/or imaging probeconstruction and/or relative position of the imaging probe to theflexible catheter. Localizing the one or more imaging elements to thetarget anatomy and/or the distal end of the flexible catheter allowspositions of the target anatomy, the distal end of the flexiblecatheter, and/or the medical tool deployed at the distal end of theflexible catheter observed within the images obtained by the one or moreimaging elements to be more easily mapped to movements and/oradjustments to the distal end of the flexible catheter and/or themedical tool so that the medical tool may be deployed within the targetanatomy. In some examples, the localizing may be obtained by combiningthe registration transform of the flexible catheter with theregistration transform of the imaging probe through a common referencepoint, such as a point on adaptor 320. In some examples, the localizingmay further include continued monitoring of the positions andorientations of the flexible catheter and/or the imaging probe usingrespective shape sensors and/or position sensor systems and/orlocalization information obtainable using images of the flexiblecatheter, the distal end of the flexible catheter, and/or the medicaltool obtained using the one or more imaging elements. In some examples,one or more fiducial markers, such as emitters and/or special markers,mounted to known locations on the flexible catheter, the distal end ofthe flexible catheter, and/or the medical tool may also contribute tothe localization.

At a process 935, a sealing probe, such as sealing probe 750, isinserted and driven toward a seal point within passageways 710. Usingprocesses similar to processes 915-725, the sealing probe is insertedinto the passageways, registered to the one or more models obtainedduring process 905, and driven toward the seal point using the one ormore plans determined during process 910. In some examples, process 935may further including positioning one or more sealing balloons, such asthe one or more sealing balloons 755, within the passageways at the sealpoint and/or a plurality of seal points. In some examples, the sealpoint can be determined as a point proximate the target location whichprovides for collapse of the passageways which lead to the targetlocation but minimizes the collapse of passageways not associated withthe target location.

At a process 940, the passageway is closed at the seal point byenlarging the one or more sealing balloons of the sealing probe. The oneor more balloons may be enlarged by injecting air, saline, and/or someother gas or fluid into the one or more sealing balloons using one ormore lumens within the sealing probe so that the one or more sealingballoons fill the passageway at the seal point, conform to the shape ofthe passageway, and conform to the shape of the flexible catheter andthe imaging probe within the passageway at the seal point.

At a process 945, one or more passageways distal to the seal point arecollapsed. In some examples, air within the one or more passageways isremoved through evacuation lumens including one or one or more flaps,one way valves, and/or the like within the one or more balloons used toseal the passageway during process 940. In some examples, air within theone or more passageways is siphoned from the one or more passagewaysusing one or more lumens in the sealing probe, the imaging, probe, theflexible catheter, and/or a device carried within the flexible cathetersuch as a biopsy needle with an open lumen.

At a process 950, the imaging probe is adjusted to obtain images of thetarget anatomy. In some examples, the images are obtained and used toaid in adjustment of the imaging probe such that the imaging probe isinserted or retracted in the passageways and rotated until the targetanatomy is in view. Because the positioning and/or orienting of the oneor more imaging elements during process 930 may be inaccurate and/or thepositioning and/or orienting may be disturbed as the one or morepassageways distal to the seal point are collapsed, the imaging probeand the one or more imaging elements may be adjusted to align theimaging field of view with the target anatomy. In some examples,position and/or orientation data from the shape sensor or positionsensor system may be used to aid the adjustment of the imaging probe. Insome examples, guidance for adjusting the imaging probe, such as hapticfeedback and/or direction hints, virtual overlays, and/or the like, maybe provided to the operator using a display system, such as displaysystem 110.

At a process 955, an image is obtained using the one or more imagingelements of the imaging probe. In some examples, when the one or moreimaging elements include one or more transducers, the image may beobtained by rotating the imaging probe to obtain a planar slice aroundthe imaging probe that is aligned with an imaging field of view, such asimaging field of view 747 and/or 637, and/or oriented with the targetanatomy. The obtained image is then analyzed to determine a location ofthe target anatomy relative to the imaging probe.

At a process 960, the medical tool is driven to the target anatomy byadjusting the flexible catheter and/or by deploying the medical toolrelative to the distal end of the flexible catheter. In some examples,the image obtained during process 955 along with the localizationdetermined during process 930 may be used to adjust the position of theflexible catheter and/or the distal end of the flexible catheterrelative to the target anatomy. In some examples, when the medical toolis biopsy needle 730, biopsy needle 730 may be driven by extending itinto the target anatomy where it may be captured within the imageobtained during process 955. Alternatively, the medical tool may beconsistent with other biopsy instruments, ablation devices,cryotherapeutic devices, drug delivery needles, and/or other surgical,diagnostic, or therapeutic tools. In some examples, when the imageobtained during process 960 does not include the target anatomy, process960 may be omitted until a real-time image of the target anatomy isobtained by the imaging probe. Processes 950-760 may then be repeated tocontinually adjust the imaging probe, obtain images, and drive themedical tool so as to provide real-time monitoring of the procedurebeing performed using the medical tool.

At a process 965, the one or more passageways collapsed during process945 are re-inflated. In some examples, the one or more passageways maybe re-inflated by deflating the one or more balloons by opening the oneor more flaps and/or the one or more valves located on the one or moreballoons used to close the passageway. In some examples, the one or morepassageways may be re-inflated by re-introducing air or another suitablegas into the one or more passageways using the one or more lumens in theflexible catheter, the imaging probe, and/or the sealing probe used tocollapse the one or more passageways during process 945. In someexamples, when processes 950-760 are not able to complete the procedure,process 965 may include partially re-inflating the one or morepassageways so that the imaging probe and/or the flexible catheter maybe repositioned and/or reoriented (e.g., by performing processes 950and/or 960 while the one or more passageways are partially re-inflated)before re-collapsing the one or more passageways by returning to process945. In some examples, the partial re-inflation of the one or morepassageways allows for more movement in the imaging probe and/or theflexible catheter because the partially collapsed one or morepassageways do not impede movement of the imaging probe and/or theflexible catheter as much as the fully collapsed one or morepassageways.

Examples

1. A method of controlling a medical system, the method comprising:

inserting a flexible catheter, a working catheter, and an imaging probeinto anatomic passageways of a patient, wherein the flexible cathetercomprises a sealing device;

driving a distal portion of the flexible catheter towards a targetanatomy to a first location, wherein the flexible catheter comprises asealing device;

driving a distal portion of the working catheter with guidance from afirst positioning system towards the target anatomy to a second locationwhere one or more medical instruments deployed through one or morelumens of the working catheter have access to the target anatomy;

driving a distal portion of the imaging probe towards the target anatomyto a third location where one or more imaging elements of the imagingprobe are able to obtain images of the target anatomy;

sealing one of the anatomic passageways at the first location using thesealing device, wherein the first location is proximal to the secondlocation and the third location;

collapsing the anatomic passageways distal to the sealing device;obtaining one or more images of the target anatomy using the imagingprobe; and

performing a procedure on the target anatomy using the one or moremedical instruments under guidance from the one or more images.

2. The method of example 1, further comprising adjusting at least one ofa position and an orientation of the imaging probe while the anatomicpassageways are collapsed.3. The method of example 1 or 2, further comprising adjusting at leastone of a position and an orientation of the working catheter while theanatomic passageways are collapsed.4. The method of any one of examples 1-3, further comprising partiallyre-inflating the collapsed anatomic passageways to allow adjustment ofat least one of a position and an orientation of at least one of theflexible catheter and the imaging probe.5. The method of any one of examples 1-4, wherein the second location isin a different branch of the anatomic passageways than the thirdlocation.6. The method of any one of examples 1-5, wherein the first location isin a first branch, the second location is in a second branch, and thethird location is in a third branch and the second branch and the thirdbranch are next generation branches to the first branch.7. The method of any one of examples 1-6, wherein the first positioningsystem comprises one or more position sensors.8. The method of example 7, wherein the one or more position sensorscomprises a fiber optic sensor.9. The method of example 7, wherein the one or more position sensorscomprises an electromagnetic sensor.10. The method of any one of examples 7-9, wherein the flexible catheterincludes the one or more position sensors to provide position andorientation of the distal portion of the flexible catheter.11. The method of any one of examples 7-9, wherein the working catheterincludes the one or more position sensors to provide position andorientation of the distal portion of the working catheter.12. The method of any one of examples 1-11, wherein driving the distalportion of the flexible catheter to the first location furthercomprises:

receiving the working catheter within a lumen of the flexible catheter,wherein a distal end of the working catheter is positioned within thedistal portion of the flexible catheter; and

driving the working catheter to the first location while received withinthe lumen of the flexible catheter.

13. The method of any one of examples 1-3, 5-9, or 12, wherein aposition and orientation of the flexible catheter is determined from theone or more position sensors in the working catheter.14. The method of example 11, wherein driving the working catheter tothe second location comprises using guidance from the one or moreposition sensors.15. The method of example 7, wherein the imaging probe includes the oneor more position sensors to provide position and orientation of thedistal portion of the imaging probe.16. The method of example 15, wherein driving the distal portion of theimaging probe to the third location comprises using guidance from theone or more position sensors.17. The method of example 15, wherein driving the distal portion of theflexible catheter to the first location further comprises:

receiving the imaging probe within a lumen of the flexible catheter,wherein a distal end of the imaging probe is positioned within thedistal portion of the flexible catheter; and

driving the imaging probe to the first location while received within alumen of the flexible catheter.

18. The method of example 17, wherein a position and orientation of theflexible catheter is determined from the one or more position sensors inthe imaging probe.19. The method of any one of examples 1-6, further comprising using asecond positioning system to guide the distal portion of the flexiblecatheter to the second location and to guide the distal portion of theimaging probe to the third location.20. The method of example 19, wherein the second positioning systemcomprises:

a multi-port adaptor comprising a plurality of channels for receivingthe working catheter, the imaging probe, and the flexible catheter; and

an insertion measurement system for providing an imaging probe insertionposition of the imaging probe and a flexible catheter insertion positionof the flexible catheter.

21. The method of example 20, further comprising:

determining a working catheter position based on the first positioningsystem;

determining a relative radial position of the working catheter, theimaging probe, and the flexible catheter based on known radial positionsof the plurality of channels;

determining a position of the distal portion of the flexible catheterbased on the relative radial position, the flexible catheter insertionposition, and the working catheter position; and

determining a position of the distal portion of the imaging probe basedon the relative radial position, the imaging probe insertion position,and the working catheter position.

22. The method of any one of examples 1-21, wherein the flexiblecatheter further comprises one or more fiducials, and the imaging probeis configured to detect the one or more fiducials to localize theimaging probe to the flexible catheter.23. The method of any one of examples 1-22, wherein the sealing devicecomprises one or more balloons.24. The method of any one of examples 1-23, wherein collapsing theanatomic passageways distal to the sealing device further comprisesremoving air from the anatomic passageways using one or more firstlumens in the working catheter, one or more second lumens in the imagingprobe, or one or more third lumens in the flexible catheter.25. The method of any one of examples 1-24, wherein the one or moremedical instruments is selected from a group consisting of a biopsyneedle, an ablation device, a cryotherapeutic device, a drug deliveryneedle, and an endoscope.26. The method of any one of examples 1-25, wherein the anatomicpassageways are airways of a lung and the target anatomy is a lesion ortumor.27. The method of any one of examples 1-9 or 22-26, wherein:

the imaging probe is fixed to the flexible catheter;

the one or more imaging elements are positioned distal to the sealingdevice;

the sealing device is positioned at the first location; and

the imaging elements are positioned at the third location.

28. The method of any one of examples 1-27, wherein the one or moreimaging elements include at least one of a plurality of phased arrayultrasound elements, a side facing ultrasound transducer, a forwardfacing ultrasound transducer, or a curved ultrasound transducer.29. The method of any one of examples 1-27, wherein the imaging probe isa radial endo-bronchial probe.30. The method of any one of examples 1-27, wherein the imaging probeincludes an imaging needle configured to be inserted into targetanatomy.

One or more elements in embodiments of the invention (e.g., method 900and/or 800) may be implemented in software to execute on a processor ofa computer system, such as control system 112. In some examples, thesoftware may be included on non-transient, tangible, machine readablemedia that includes executable code that when run by one or moreprocessors may cause the one or more processors to perform the processesof method 900 and/or 800. Some common forms of machine readable mediathat may include the processes of method 900 and/or 800 are, forexample, floppy disk, flexible disk, hard disk, magnetic tape, any othermagnetic medium, CD-ROM, any other optical medium, punch cards, papertape, any other physical medium with patterns of holes, RAM, PROM,EPROM, FLASH-EPROM, any other memory chip or cartridge, and/or any othermedium from which a processor or computer is adapted to read. In someexamples, the software may be downloaded via computer networks such asthe Internet, Intranet, etc. As described herein, operations ofaccessing, detecting, initiating, registered, displaying, receiving,generating, determining, moving data points, segmenting, matching, etc.may be performed at least in part by the control system 112 or theprocessors thereof.

Note that the processes and displays presented may not inherently berelated to any particular computer or other apparatus. The requiredstructure for a variety of these systems will appear as elements in theclaims. In addition, the embodiments of the invention are not describedwith reference to any particular programming language. It will beappreciated that a variety of programming languages may be used toimplement the teachings of the invention as described herein.

While certain exemplary embodiments of the invention have been describedand shown in the accompanying drawings, it is to be understood that suchembodiments are merely illustrative of and not restrictive on the broadinvention, and that the embodiments of the invention not be limited tothe specific constructions and arrangements shown and described, sincevarious other modifications may occur to those ordinarily skilled in theart.

1. A medical system for performing a minimally invasive procedure withinanatomic passageways, the medical system comprising: a flexible catheterincluding a plurality of first lumens and a sealing device; an imagingprobe including one or more imaging elements wherein the imaging probeis configured to be slideably received within a first of the pluralityof first lumens; a working catheter configured to be slideably receivedwithin a second of the plurality of first lumens, the working catheterincluding one or more second lumens, wherein one of the one or moresecond lumens is configured to slideably receive a medical instrument;and a positioning system configured to determine a position of at leastone of a distal portion of the flexible catheter, a distal portion ofthe imaging probe, or a distal portion of the working catheter withinthe anatomic passageways.
 2. The medical system of claim 1, wherein atleast one of the flexible catheter, the imaging probe, or the workingcatheter includes one or more position sensors comprising at least oneof a fiber optic sensor or an electromagnetic sensor. 3-4. (canceled) 5.The medical system of claim 1, wherein the flexible catheter or theworking catheter further includes one or more fiducials, wherein theimaging probe is configured to detect the one or more fiducials.
 6. Themedical system of claim 1, wherein the one or more imaging elementsinclude at least one of a plurality of phased array ultrasound elements,a side facing ultrasound transducer, a forward facing ultrasoundtransducer, or a curved ultrasound transducer.
 7. (canceled)
 8. Themedical system of claim 1, wherein the imaging probe includes an imagingneedle configured to be inserted into target anatomy.
 9. The medicalsystem of claim 1, wherein the sealing device comprises one or moreballoons that are inflated to seal the anatomic passageways at a sealinglocation.
 10. The medical system of claim 9, wherein the one or moreballoons are located at multiple points along the flexible catheter. 11.The medical system of claim 9, wherein the medical system is furtherconfigured to collapse the anatomic passageways by removing air from theanatomic passageways distal to the sealing location using at least oneof a third lumen of the plurality of first lumens, the one or moresecond lumens in the working catheter, or one or more third lumens inthe imaging probe.
 12. The medical system of claim 11, wherein thesealing device includes one or more flaps or valves configured to removeair from the anatomic passageways as the anatomic passageways collapse.13. (canceled)
 14. The medical system of claim 1, wherein the medicalinstrument is a biopsy needle, an ablation device, a cryotherapeuticdevice, a drug delivery needle, or an endoscope. 15-30. (canceled)
 31. Amedical system for performing a minimally invasive procedure withinanatomic passageways, the medical system comprising: a working cathetercomprising one or more first lumens, one of the one or more first lumensof the working catheter being configured to slideably receive a medicalinstrument; an imaging probe comprising one or more imaging elementspositioned near a distal portion of the imaging probe to obtain imagesof a target anatomy; a flexible catheter comprising a sealing device;and a positioning system for determining at least one of a position of adistal portion of the working catheter, a position of the distal portionof the imaging probe, or a position of a distal portion of the flexiblecatheter within the anatomic passageways.
 32. The medical system ofclaim 31, further comprising a multi-port adaptor comprising a pluralityof channels for receiving the working catheter, the imaging probe, andthe flexible catheter.
 33. The medical system of claim 32, wherein thepositioning system includes at least one position sensor comprising atleast one of a fiber optic sensor or an electromagnetic sensor.
 34. Themedical system of claim 33, wherein the at least one position sensorincludes a first position sensor fixedly coupled to the workingcatheter.
 35. The medical system of claim 34, wherein the positioningsystem further includes: an insertion measurement system for providingan imaging probe insertion position of the imaging probe or forproviding a flexible catheter insertion position of the flexiblecatheter; and one or more processors configured to: determine a relativeposition of the working catheter, the imaging probe, or the flexiblecatheter based on a known configuration of the plurality of channels;determine the position of the distal portion of the working catheterbased on data from the position sensor; and determine the position ofthe distal portion of the imaging probe based on the relative position,the position of the distal portion of the working catheter, the imagingprobe insertion position, and the images of the target anatomy. 36.(canceled)
 37. The medical system of claim 33, wherein the at least oneposition sensor includes a second position sensor received within one ormore second lumens of the imaging probe.
 38. The medical system of claim33, wherein the working catheter further comprises one or morefiducials, and the imaging probe is configured to detect the one or morefiducials. 39-43. (canceled)
 44. The medical system of claim 31, whereinthe sealing device comprises one or more balloons that are inflated toseal the anatomic passageways at a sealing location.
 45. The medicalsystem of claim 44, wherein the one or more balloons are located atmultiple points along the flexible catheter.
 46. The medical system ofclaim 31, wherein the medical system is further configured to collapsethe anatomic passageways distal to a sealing location by removing airfrom the anatomic passageways using at least one of the one or morefirst lumens in the working catheter, one or more second lumens in theimaging probe, or one or more third lumens in the flexible catheter.47-48. (canceled)